Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Selfcare, Inc. — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

29 daysmedian FDA review time

142 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K002867	INVERNESS MEDICAL OVULATION PREDICTOR TEST	Selfcare, Inc.	2000-10-12	29
K002134	ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM	Selfcare, Inc.	2000-08-07	24
K002049	INVERNESS MEDICAL EARLY PREGNANCY TEST	Selfcare, Inc.	2000-07-27	24
K001427	MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SY	Selfcare, Inc.	2000-06-02	28
K000583	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Selfcare, Inc.	2000-03-17	24
K993632	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Selfcare, Inc.	1999-11-12	16
K991480	EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP	Selfcare, Inc.	1999-09-17	142
K991466	EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PRE	Selfcare, Inc.	1999-05-25	28
K991386	EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDIC	Selfcare, Inc.	1999-05-25	34
K990939	FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Selfcare, Inc.	1999-04-20	29
K983468	FASTTAKE ADAPTER, MODEL # P/N 020-072-01	Selfcare, Inc.	1998-12-17	77
K970707	ELECT II BLOOD GLUCOSE MONITORING SYSTEM	Selfcare, Inc.	1997-06-20	114
K961985	ELECT BLOOD GLUCOSE MONITORIG SYSTEM	Selfcare, Inc.	1996-09-05	107
K960053	SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM	Selfcare, Inc.	1996-06-28	176
K960436	SELFCARE EARLY PREGNANCY TEST	Selfcare, Inc.	1996-03-19	48

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda